PMA P130008S113

Device: Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S113
Product code: MNQ
Decision date: 2024-08-30
Classification: Anesthesiology
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: updates to the Model 4063 Stimulation Lead and the Model 4340 Sensing Lead Final Pack manufacturing process

Current openFDA PMA Record#

Device: Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S113
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2024-08-30
Decision code: OK30
Date received: 2024-07-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: updates to the Model 4063 Stimulation Lead and the Model 4340 Sensing Lead Final Pack manufacturing process